Use of Atropine in Tredmill Stress Testing - Full Text View

Sponsored by:	HaEmek Medical Center, Israel
Information provided by:	HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:	NCT00623207

Purpose

The aim of this study is to evaluate the Safety and feasibility of atropine added during treadmill stress testing in patients with chronotropic incompetence or poor exercise capacity.

Our hypothesis is that we can increase heart rate by using atropin in these patients, so we will achieve more conclusive results.

Condition	Intervention	Phase
Chest Pain	Drug: Atropine	Phase III

MedlinePlus related topics: Chest Pain Exercise and Physical Fitness

Drug Information available for: Atropine Atropine sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Safety and Feasibility of Atropine Added During Treadmill Stress Testing in Patients With Chronotropic Incompetence or Poor Exercise Capacity.

Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:

1- To characterize patients who can't achieve target heart rate at treadmill exercise test.2- To evaluate atropine added during treadmill stress testing in order to increase heart rate and achieave conclusive test. [ Time Frame: 1 yaer ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	150
Study Start Date:	December 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Pateints who achieve target haert rate or conclusive test will not be given Atropine	Drug: Atropine I.V Atropine 0.5mg up to 2 mg
2: Active Comparator Patients who won't achieve tarhet heart rate or conclusive results will be given Atropine	Drug: Atropine I.V Atropine 0.5mg up to 2 mg

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with chest pain without evidence of ischemia eligible for exercise test.
Age> 18 years old

Exclusion Criteria:

Absolute:

Patients with LBBB
Unstable Angina
Recent Myocardial Infarction
Un controlled Arrythmia
Congestive heart faliure
Severe symptomatic valvular heart disease
Acute Pulmonary Embolism
Acute perimyocarditis
Acute aortic dissection

Relative:

Lt main stenosis
Severe hypertention (Systolic> 200 mmHg; Diastolic > 100 mmHg)
Cardiomyopathy
Obstructiove abnormalities
Psychiatric disorders
High degree AV Block

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00623207

Contacts

Contact: Mohamed Jabaren, MD	972-4-6495273	jabaren_mo@clalit.org.il
Contact: Yoav Turgeman, MD	972- 4- 6494144	yoav_t@clalit.org.il

Locations

Israel
Heart Institute, Ha'Emek Medical Center	Recruiting
Afula, Israel, 18100
Contact: Mohamed Jabaren, MD 972- 4- 6495273 jabaren_mo@clalit.org.il

Sponsors and Collaborators

HaEmek Medical Center, Israel

More Information

Responsible Party:	Ha'Emeh Medical Center, Afula ( Dr. Mohamed Jabaren )
Study ID Numbers:	07-0139 EMC
Study First Received:	February 14, 2008
Last Updated:	February 22, 2008
ClinicalTrials.gov Identifier:	NCT00623207
Health Authority:	Israel: Ethics Commission

Keywords provided by HaEmek Medical Center, Israel:

Chest Pain Low work Capacity Rate Incompetence

Study placed in the following topic categories:

Signs and Symptoms
Stress
Pain
Atropine
Chest Pain

Additional relevant MeSH terms:

Parasympatholytics
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Cardiovascular Agents
Cholinergic Agents
Pharmacologic Actions

Muscarinic Antagonists
Adjuvants, Anesthesia
Mydriatics
Autonomic Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009